Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transpyloric tube feeding, Gastric tube feeding.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia, Gastroesophageal Reflux. Basic parameters: 1 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Trial Comparing Transpyloric to Gastric Feeding in Very Preterm Infants With Bronchopulmonary Dysplasia
Overview
The goal of this clinical trial is to learn if transpyloric tube feeding (feeding directly into the small intestine) versus gastric tube feeding tolerably and effectively reduces gastroesophageal reflux in infants born premature who have been diagnosed with bronchopulmonary dysplasia. The main questions this trial aims to answer are: Does transpyloric as compared to gastric tube feeding result in differences in the amount of experienced hypoxemia (low oxygen level in the blood) or serious adverse events? Does transpyloric as compared to gastric tube feeding reduce the frequency and severity of gastroesophageal reflux (GER) measured using 24 hour esophageal pH-multichannel intraluminal impedance (pH-MII) monitoring? Participants will: Undergo pre-trial 24 hour pH-MII monitoring to determine baseline severity of GER. Be randomly assigned to receive transpyloric or gastric tube feeding for 2 weeks. Undergo repeat pH-MII at the end of the 2 week trial to assess for change in GER. Undergo continuous pulse oximetry to record level of hypoxemia during the 2 week trial. Undergo saliva and airway (if supported by a breathing tube) fluid collection to measure biomarkers of GER. Be monitored clinically for possible adverse events.
Interventions
- Other Transpyloric tube feeding
Tube feeding into the small bowel - Other Gastric tube feeding
Tube feeding into the stomach
Primary outcome measures
- Proportion (%) of time per day with oxygen saturation <80% [Time frame: During the 2 week trial]
- Serious adverse events [Time frame: Until hospital discharge]
Secondary outcome measures (12)
- Total number of gastroesophageal reflux (GER) episodes [Time frame: 24 hours]
- Proportion of GER episodes reaching the proximal pH-MII sensor [Time frame: 24 hours]
- Total number of pH (acid) only reflux episodes [Time frame: 24 hours]
- Salivary and tracheal pepsin concentration [Time frame: 1 day prior to initiating the trial and on trial day 7 and 14.]
- Salivary and tracheal total bile acid concentration [Time frame: 1 day prior to initiating the trial and on trial day 7 and 14.]
- Intermittent hypoxemic episodes [Time frame: During the 2 week trial]
- Prolonged hypoxemic episodes [Time frame: During the 2 week trial]
- Clinically diagnosed aspiration events [Time frame: During the 2 week trial]
- Respiratory severity score [Time frame: During the 2 week trial]
- Face, Legs, Activity, Cry, Consolability (FLACC) behavioral pain scale [Time frame: During the 2 week trial]
- Total daily narcotic exposure [Time frame: During the 2 week trial]
- Feeding tube replacement [Time frame: During the 2 week trial]
Eligibility criteria
Inclusion criteria
- Birth <32 weeks' gestation
- Current postmenstrual age of 36-65 weeks
- Grade 2-3 bronchopulmonary dysplasia (BPD: treatment with positive airway pressure at 36 weeks' PMA) or grade 1 BPD (treatment with ≤2L/min flow nasal cannular at 36 weeks' PMA) with subsequent need for prolonged positive airway pressure and full enteral tube feedings
- Treatment with positive airway pressure (high flow nasal cannula, non-invasive positive airway pressure, or invasive ventilation) at enrollment
(4) Full gastric tube feedings (≥100mL/kg/d) at the time of enrollment (5) Parental consent to participate
Note: At least 20 infants receiving invasive ventilation will be enrolled to enable endotracheal biomarker testing.
Exclusion criteria
- Transpyloric feedings received within 7d of enrollment
- Use of a gastric acid suppression, GI promotility drug, or caffeine within 7d of enrollment
- History of gastrostomy tube placement, gastric fundoplication, or bowel resection resulting in short gut with contraindication to transpyloric feeding
- Plan to wean off positive airway pressure (for non-intubated subjects) or to be extubated to non-invasive support (for subjects receiving invasive ventilation) within the 2wk trial
- Known intolerance to transpyloric feeding
- Persistent >20% endotracheal tube leak (for intubated subjects only)
- Active treatment with an investigational therapy as part of another interventional trial
- severe congenital or genetic abnormality that adversely affects GI or cardiopulmonary function
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Stanford University — Palo Alto
- Children's Hospital Colorado — Denver
- Children's Mercy Hospital — Kansas City
- Children's Hospital of Philadelphia — Philadelphia
Identifiers
NCT: NCT06534359 · 24-022805 · 1R21HD113897-01A1